An interventional study of general practice follow-up and ear-nose-throat (ENT) specialist follow-up in Otitis, sponsored by Norwegian University of Science and Technology. Completed at 6 sites in Norway. Open to participants aged 3 Years to 10 Years. Per ClinicalTrials.gov, last updated 2023-11-02.
Sponsored by Norwegian University of Science and Technology · Not applicable, Interventional, and Health services research
A large number of children with otitis media undergo surgery with ventilation tubes (VTs) placed in the tympanic membrane. This is done to improve hearing and speech development and to reduce ear complaints. The long-term results of VTs are unclear. Follow-up care is required to assure that the tubes are functional, hearing loss has been corrected, and potential complications are properly diagnosed and managed. Guidelines regarding follow-up care give different advices concerning when, how and by whom the controls should be made.
The primary goal of this study is to investigate if follow-up care after surgery with VTs of children aged 3-10 years can be done by general practitioners instead of specialists without negative consequences for the patient.
In the study the child's hearing and speech development, middle ear function, subjective complaints and complications will be assessed. User satisfaction and other aspects related to the quality of control will also be assessed.
If the study shows that follow-ups after surgery with VTs can be done on the level of primary care without loss of care quality, specialist health care services will be spared and cost-effectiveness for the overall healthcare system will improve.
Remark: the change in age range of included children from 4-10 to 3-10 was approved by REK (ethics committee) in November 2018.
Exclusion Criteria:
post-surgery follow-up by general practitioner
Procedure: general practice follow-up
post-surgery follow-up by ear-nose-throat (ENT) specialist
Procedure: ear-nose-throat (ENT) specialist follow-up
Post-surgery follow-up by general practitioner
Post-surgery follow-up by ear-nose-throat (ENT) specialist
audiogram
pure tone thresholds in decibel (dB) at 0.25-0.5-1-2-4 kHz
Time frame: 2 years
audiogram
pure tone thresholds in decibel (dB) at 0.25-0.5-1-2-4 kHz
Time frame: 4 years
Plan to share: Undecided
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Norwegian University of Science and Technology